On September 12, 2019, the U.S. Food and Drug Administration (FDA) will begin removinginactive drug listings from its drug listing database. In other words, inactive drug listings will no longer be “listed” with FDA, as required by law. A removed drug listing can be...
Between October 1 and December 31, certain Food and Drug Administration (FDA)-registered facilities must renew their registrations. Here are some things you need to know to ensure your renewal is completed on time. Medical device establishments: The process of paying...
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Drug pricing in the United States has been a complicated issue since the regulation of food and drugs begun in 1906. Understandably, high drug prices and efforts to bring them under control are hot topics in the news; it is estimated that prescription drugs account...
President Trump has suggested a possible executive order to lower drug prices, which is to establish new trade policies that would strengthen intellectual property rights (IPR) in other countries markets. IPR refers to legal rights given to inventors or innovators of...
The US drug approval process is long and costly, and pharmaceutical development companies pass the extensive costs of research, user fees, and monopoly rent on to American consumers. Essentially, U.S. patients have been...
Recent headline: Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated Our take... Yeah...not so fast. I expect the Trump-team follow up to be, "we meant 75-80% of the really bad regulations will disappear -- and most likely only in...
Between October 1 and December 31 this year, all FDA-registered facilities must renew their registrations. Our team has handled registration renewal for hundreds of facilities. Here are some of our best tips for ensuring the renewal season goes smoothly. Medical...
Between October 1 and December 31 every year, FDA-registered facilities around the world must submit renewals to their registrations (except registered food facilities, which must renew every even-numbered year). If your facility is registered with FDA, then this...
While generic drug laws and policy have brought down the cost of Rx drugs for many Americans, recent legislation, such as the Generic Drug User Fee Amendments of 2012 (GDUFA) is reversing that trend and significantly increasing the cost of generic drugs. GDUFA added...
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